FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

1,198 results for "regulatory technology services, llc"
433–456 of 1,198
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 28, 2016
Arterys Software v2.0
K162513 · LLZ
Arterys, Inc.
Radiology · 50d
Cleared Oct 18, 2016
IntelliSpace Portal Platform
K162025 · LLZ
Philips Medical Systems Nederlands B.V.
Radiology · 88d
Cleared Oct 03, 2016
Lumify Ultrasound System
K162549 · IYN
Philips Health Care
Radiology · 20d
Cleared Sep 28, 2016
Acuson Freestyle Ultrasound System
K162417 · IYN
Siemens Medi Cal Solutions, Inc.
Radiology · 29d
Cleared Sep 14, 2016
CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System
K162329 · IYN
Philips Health Care
Radiology · 26d
Cleared Sep 14, 2016
dS FootAnkle I6CH 1.5T Coil
K162177 · MOS
Invivo Corporation
Radiology · 41d
Cleared Sep 08, 2016
SonoSite iViz Ultrasound System
K162288 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 24d
Cleared Sep 06, 2016
ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound System
K162243 · IYN
Siemens Medi Cal Solutions, Inc.
Radiology · 27d
Cleared Sep 01, 2016
XP202
K161922 · EIH
3M Deutschland GmbH
Dental · 50d
Cleared Aug 31, 2016
1.5T and 3.0T 16 CH GE Shoulder Coils
K162001 · MOS
Invivo Corporation
Radiology · 42d
Cleared Aug 29, 2016
BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems
K161777 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 61d
Cleared Aug 26, 2016
RS80A Diagnostic Ultrasound System
K162094 · IYN
Samsung Medison Co., Ltd.
Radiology · 29d
Cleared Aug 18, 2016
SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System
K162045 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 24d
Cleared Aug 10, 2016
5D Viewer
K161955 · LLZ
Samsung Medison Co., Ltd.
Radiology · 23d
Cleared Jul 28, 2016
ACUSON NX2 Diagnostic Ultrasound Systems
K161787 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Jul 26, 2016
VITRUVIAN ULTIMATE ASPIRATOR
K161722 · QPB
Black & Black Surgical, Inc.
General & Plastic Surgery · 34d
Cleared Jul 15, 2016
FlexSeal Introducer Sheath with Hydrophilic Coating
K161659 · DYB
Libramedical, Inc.
Cardiovascular · 29d
Cleared Jun 23, 2016
FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM
K160540 · BZE
Flexicare Medical Limited.
Anesthesiology · 118d
Cleared Jun 15, 2016
NormaTec PCD-T and PCD-B
K161346 · JOW
NormaTec Industries, LP
Cardiovascular · 30d
Cleared Jun 09, 2016
Oak Ridge Products Sharps Containers
K161180 · MMK
Oak Ridge Products, LLC
General Hospital · 43d
Cleared Jun 03, 2016
Halo One Thin-Walled Guiding Sheath
K161183 · DYB
C.R. Bard, Inc.
Cardiovascular · 37d
Cleared May 13, 2016
SonoSite iViz Ultrasound System
K161119 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 23d
Cleared Apr 19, 2016
Fujifilm Sonosite Vevo MD Imaging System
K160674 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 40d
Cleared Apr 13, 2016
NormaTec Pulse and NormaTec Pulse Pro
K160608 · IRP
NormaTec Industries, LP
Physical Medicine · 41d